1. Field of the Invention
The invention relates to various indicators for identifying reprocessed medical instruments. More particularly, the invention relates to reprocessing indicators composed of ethylene oxide (EtO) indicator ink and/or non-critical, breakable components of the medical instruments.
2. Description of the Prior Art
Engineers specializing in the design and manufacture of medical instruments commonly attempt to improve upon previously existing medical instruments by enhancing the usage of these instruments. By improving the medical instrument, the possibility for user error is often drastically reduced. Through improved engineering, these engineers attempt to eliminate the gap between the best surgeon and the worst surgeon through careful product design. Similarly, they try to transform patient care through inventive product design. Many of their medical instruments are designed for minimally invasive procedures, resulting in quicker surgeries, lower risk of complications, less pain, shorter recovery time and lower costs.
The development of improved manufacturing techniques, advanced materials and concerns regarding contamination have led to the development of medical instruments designed for single use applications. For example, many laparoscopic devices, such as surgical staplers and trocars, are designed as single use items that are intended to be immediately disposed of after use.
A recent trend in the medical community is reprocessing of single use medical instruments, by parties other than the original equipment manufacturer, instead of discarding them after use. During reprocessing, the medical instruments are disassembled, cleaned and sterilized. They are then reassembled for future use.
However, many of the medical instruments reprocessed for further use are specifically designed only for use during a single procedure. Consequently, the performance of the medical instruments decline after reprocessing, since the components making up the medical instrument are not adapted for multiple uses and will degrade in performance when used beyond their intended lifespan. For example, reprocessing of the cutting devices on trocars extends these devices beyond their intended mission life and may result in duller blades. A greater force, therefore, is needed to make an initial incision, causing more trauma to the patient. In addition, the use of greater force increases the potential for error during the surgical procedure.
The reprocessing itself can also cause serious problems. Some of the components of single use medical instruments cannot be reused. Thus, the reprocessor must manufacture these components. The third party reprocessors often do not satisfy the tolerances required for proper operation of the medical instruments as the third party reprocessors do not have the in depth knowledge of the device application or design required to create proper replacement parts.
As reprocessing of medical instruments proliferates, it has become very difficult to identify if an item has in fact been reprocessed or if it is the original medical instrument delivered by the original manufacturer. Doctors usually do not even know if a medical instrument has been reprocessed, since the medical instrument is commonly unpacked prior to use by the doctor and any reprocessing notification is located on the packaging of the medical instrument. The FDA requires labeling of only the package of the reprocessed item with the new manufacturer information; the medical instrument itself is not required to be marked. In fact, some hospitals instruct the staff responsible for opening medical instruments and setting up the medical instruments for surgery not to inform the doctor as to whether the medical instruments have been reprocessed.
Often, when these medical instruments have been reprocessed and used for a second, third or fourth time, they fail and are returned to the original product manufacturer, for example, assignee Ethicon Endo Surgery, Inc., of the present invention. The original manufacturers are commonly obligated to replace defective products (i.e., those original medical instruments which are defective and have not been reprocessed). However, there is no economical way to distinguish between a product that failed as a result of some defect in the original manufacture thereof and one that failed because of third party reprocessing.
In 2004, the FDA changed some of the regulations relating to third party reprocessing. The FDA rescinded third party re-processors 510(k). This heavily restricts the types of tools that a reprocessor can reprocess. While this is good for original equipment manufacturers, there is a good chance the third party reprocessors will either find a way around the current restrictions or that the 510(k) will be reinstated. In fact, the 510(k)s for one party has been reinstated as of April 2005.